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Molecular ‘grenades’ from GenSpera reel in PhI liver cancer success

Molecular ‘grenades’ from GenSpera reel in PhI liver cancer success

http://www.fiercedrugdelivery.com/story/molecular-grenades-genspera-reel-phi-liver-cancer-success/2013-10-22

October 22, 2013 | By Michael Gibney

Texas biotech GenSpera touted successful Phase I data this week for its prodrug candidate designed to target solid tumors. The drug is the first to take advantage of the enzymatic action of the prostate-specific membrane antigen (PSMA), which effectively “pulls the pin on the grenade” of the uniquely delivered drug.

In its first-in-human study of GenSpera’s lead candidate G-202 in 44 patients with solid tumors who failed on earlier therapies, 27% had a prolonged stable disease of more than 9 months. In a subset with hepatocellular carcinoma, a type of liver cancer, two out of 5 patients showed stabilization after failing on previous standards of care.

The prodrug includes the cell-killing agent 12ADT, which is injected attached to a targeting and masking peptide. GenSpera CEO Craig Dionne likens this to a grenade with a pin. When the peptide reaches the tumor cell, it encounters the PSMA enzyme, which plays a double role: first, it acts as a targeting mechanism for the peptide to reach the tumor, and second, it cleaves the peptide to release the cell-killing 12ADT within the cell, like a pin from the grenade.
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“The beauty of the molecule is it should be activated only in the tumor,” Dionne told FierceDrugDelivery. “It’s designed not to come back into the bloodstream–in animal studies, there was no effect on the liver, no effect on the cardiovascular system, no effect on bone marrow. We do see some damage in the kidney on high doses, which is expected and completely reversible, but overall it shows a tremendous application from animals to humans.”

GenSpera is now enrolling a Phase II trial to further explore G-202’s effect on liver cancer compared with the treatment Nexavar, marketed by Bayer and Onyx Pharmaceuticals ($ONXX). GenSpera expects preliminary results early next year with 9 patients enrolled already, Dionne said. All included, the publicly traded company has raised about $25 million, which Dionne said should take them through this study and toward uplisting to the Nasdaq.

The company also plans to begin testing the compound on glioblastoma brain tumors early next year.

“Because we take advantage of the enzymatic activity of PSMA, it’s a huge amplification,” Dionne said. “For every active enzyme on the surface of the cell, we have 1000 active warheads. And we’re the only ones taking advantage of the enzymatic action of PSMA.”

– here’s the release

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Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

BioWorld International

BioWorld – The Daily Biopharmaceutical News Source from Thomson Reuters

 

Canbridge, Azaya Ink Deal to Develop ATI-1123 for NSCLC

 

By Shannon Ellis
Staff Writer

Tuesday, September 24, 2013

SHANGHAI – Beijing newcomer Canbridge Life Sciences Ltd. has partnered with emerging nanotech specialist Azaya Therapeutics Inc., of San Antonio, to develop non-small-cell lung cancer (NSCLC) treatment ATI-1123 in China and North Asia.

ATI-1123 is a liposomal formulation of docetaxel that has successfully completed U.S. FDA-approved Phase I trials for multiple solid tumor cancers. Lung cancer is the most prevalent solid tumor cancer in China.

The in-licensing deal for ATI-1123 marks Canbridge’s unofficial launch. Small in size, the 10-person team comes with a strong pedigree. Founder and CEO James Xue was the founding general manager of Genzyme China and is an early returnee who came back to China with an MBA and PhD from the U.S. Crystal Xu heads up clinical development and is the former director of medical and regulatory affairs at Genzyme.

“We are focusing on diseases that most affect the quality of life of Chinese and East Asians and on patients that are also the most underserved,” Xue noted. “Over time, we will build a robust pipeline of drugs and devices in late-stage clinical development that originated at other biopharmaceutical companies outside our region and develop and launch them for China, Taiwan and South Korea. We will not be doing any discovery research. We are focusing on development.”

Licensing a treatment for lung cancer promises to be a good start in a country where smoking and air pollution are rampant. China is the largest producer and consumer of cigarettes in the world. Lung cancer has been found to be two to three times more prevalent in heavily polluted cities.

cheapest viagra uk Even better, majority of these drugs are considered safe because the key components are derived from natural sources. Insufficient blood supply leads the cialis in india man to erectile dysfunction. This can damage endothelial cells and increase the length of the male organ by on line levitra few inches. If vardenafil sale any negligence happens during consumption then this may develop various threatening like headaches, stomach pain, tiredness, dizziness, cough, sinus, swelling, anxieties, depression, behavior change or muscle weakness. A 2012 report from the National Central Cancer Registry pointed out that six people are diagnosed with lung cancer every minute on average, which adds up to about 700,000 diagnosed cases each year. The incidence of lung cancer has increased fivefold in the past 30 years, and the mortality rate has jumped 500 percent without an effective cure.

“In China, over two-thirds of the newly diagnosed lung cancer patients are not eligible for surgery,” Xue said. “Their only options are chemotherapy and radiation. We are racing against time to develop and deliver a more effective treatment to Chinese and Asian lung cancer patients. We see ATI-1123 as a promising potential new treatment in this underserved Asian market.”

ATI-1123 passed Phase I trials in the U.S. with 88 percent of 29 patients using the drug to stabilize the disease.

Under terms of the agreement with Azaya, Canbridge will finance the development and commercialization of ATI-1123 for China, South Korea and Taiwan and will make undisclosed royalty and milestone payments. Phase II trials are planned by Azaya in the U.S. for the use of the drug in NSCLC, gastric cancer, pancreatic cancer and soft-tissue sarcoma.

“Our commercialization strategy for ATI-1123 is to seek approval in the U.S. and the European Union, primarily. However, the Canbridge opportunity was presented, and we felt it was too good to pass up,” said Mike Dwyer, president and CEO of Azaya Therapeutics. “The people who comprise the Canbridge team were responsible for Chinese regulatory approval of several leading Genzyme products. We know them personally and know they only take on drugs they believe will suit their market.”

Azaya’s proprietary technology “improved” docetaxel with a liposomal formulation that, according to Azaya’s licensing proposal, “provides longer exposure to the drug at the site of the tumor while reducing systemic toxicities.” The most common treatment for breast and prostate cancer is docetaxel (Taxotere, Sanofi-Aventis), but the drug can be highly toxic with serious side effects.

Xue said that the nanotechnology developed by Azaya is what makes the drug promising.

ATI-1123 encapsulates the highly toxic cancer agent in a liposomal coating with a diameter of 90 nm, which is smaller than a blood cell.

“Liposome encapsulation works because cancer tumors have leaky vasculature and nano-sized particles can be absorbed and retained,” said Xue. “In turn, the active ingredient is released more slowly and at a higher concentration, resulting potentially in higher levels of efficacy with a much lower side-effect profile.”

Azaya is private biotech firm set up in 2003. The company uses a targeted nanotechnology platform called Protein Stabilized Liposomes to deal with problems created by water insoluble active pharmaceutical ingredients. Also in Azaya’s pipeline is ATI-0918 (generic Doxil/Caelyx), which has been approved as an investigational new drug and is undergoing bioequivalency tests in ovarian cancer.

 

 

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Azaya CEO Mike Dwyer is looking to expand opportunity with licensing agreement

SAN ANTONIO BUSINESS JOURNAL

Sep 20, 2013, 5:00am CDT

Azaya CEO Mike Dwyer is looking to expand opportunity with licensing agreement

http://www.bizjournals.com/sanantonio/print-edition/2013/09/20/azaya-ceo-mike-dwyer-is-looking-to.html?s=image_gallery

Mike Dwyer, the CEO of Azaya Therapeutics Inc., discusses his company’s exclusive licensing agreement with CANbridge Life Sciences.

Azaya Therapeutics Inc., a clinical-stage oncology company, has entered into an exclusive licensing agreement with CANbridge Life Sciences, which will develop and commercialize the San Antonio-based company’s lead compound, ATI-1123, for non-small-cell lung cancer in China, South Korea and Taiwan.

As part of the agreement, CANbridge, which is based in Beijing, China, will fund clinical development in that country, as well as in North Asia, collaborating with Azaya on clinical trial design. Financial terms of the deal have not been disclosed, but Azaya President Mike Dwyer says the partnership creates greater international opportunities for the San Antonio-based bioscience company. We asked Dwyer about the deal and its potential impact

Q: Why did Azaya decide to enter into a licensing
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A: Our commercialization strategy for ATI-1123 is to seek approval in the United States and European Union, primarily. However, the CANbridge opportunity was presented and we felt it was too good to pass up. We know (the CANbridge team) personally and know they only take on drugs they believe will suit their market. We have a high degree of trust in their ability to get the job done.

Q: Does Azaya have any concerns about protecting its intellectual property in China?

A: One of the big concerns people have with China is what happens to the intellectual property. The trust factor of who you do business with and how they are going to deal with you really gets highlighted. (CANbridge) is as familiar with this problem as we are. CANbridge and Azaya are going to share the rewards of this effort. So it is in their best interest to keep those rewards as high as they can so we have more to share.

Q: What impact could this relationship have on treatment outside the U.S.?

A: It could be phenomenal. One of the issues we have with chemotherapy products is their toxicity. In the United States, all of our oncologists have learned how to deal with that toxicity. In countries outside of the United States, the usage of our chemotherapy is not as high because of that toxicity factor. So in China, and in other countries outside the U.S., the type of product we are developing makes a lot more sense and could have a much higher use.

Q: What level of economic impact could this relationship with CANbridge have on Azaya?

A: Potentially in China, we could develop sales of $400 million to $500 million annually. That would be an enormous impact on our long-term sales and our profitability.

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Azaya Therapeutics expands operations with roll out of Parexo Labs

http://www.bizjournals.com/sanantonio/blog/2013/07/azaya-therapeutics-expands-operations.html

Jul 8, 2013, 11:16am CDT

W. Scott Bailey

Azaya Therapeutics expands operations with roll out of Parexo Labs

Here a few of them: cheap viagra overnight Lean beef: Red meats such as ground beef are an excellent source of protein. X-ray aimhousepatong.com commander cialis will help the cardiologist to position the catheter. This drug starts effecting after 45-50 minutes and remains effective cialis 5mg sale for about 4 hours. Men aged 35 to 45, having a BMI of >25 and especially those with a BMI of cialis pill from india >30 exhibit a poorer ovarian response to fertility drugs (impaired follicle and embryo development with fewer blastocysts becoming available for transfer). Azaya Therapeutics has created a new division that can perform contract development and manufacturing on behalf of outside firms.

Azaya Therapeutics Inc. has launched a new division called Parexo Labs. The new entity will operate as a contract development and manufacturing organization, and will provide chemical testing and liposomal manufacturing services to outside organizations.

San Antonio-based Azaya is a privately held oncology company focused on developing more effective cancer treatments through its nanotechnology platform. Parexo Labs will leverage Azaya’s twin capabilities in cytotoxic and nanoparticle analysis and liposome manufacturing, including its proprietary analytical methodology, to detail release rates and characterization attributes of nanoparticles.

“Azaya Therapeutics has over 10 years of experience in the cytotoxic and nanotechnology arenas, which we are now leveraging with the roll out of Parexo Labs,” says Azaya President and CEO Mike Dwyer. “Through Parexo, we can apply these analytical capabilities and development methodologies to organizations in need of them for their own development programs.”

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Azaya Therapeutics Announces Launch of CDMO, Parexo Labs

Oncology firm Azaya Therapeutics Inc. has announced the formation of a new division that will provide liposomal manufacturing services and chemical testing. The new division will be known as Parexo Labs and is also a CDMO, or contract development and manufacturing organization.

Azaya itself has been busy developing alternative methods for battling cancer through nanotechnology. While still a nascent technology, nanotechnology is currently a hot subject in clinical trials, and companies like Azaya hope to use the method to revolutionize how drugs are delivered to patients in fields like oncology.

It helps in improving female fertility as generic levitra pill well. This quality of healthy, firm and sturdy http://secretworldchronicle.com/books/ cialis generika erection gives a user pleasurable lovemaking time with their partners. These foods replenish the secretworldchronicle.com viagra pill for sale skeletal needs of the body. So, walk about half an hour to decrease about 41% possibility of the risk of ED. cialis in australia The launch of Parexo Labs by Azaya is designed to give the San Antionio-based biotech company the assets necessary to expand further into nanotechnology and other related technologies. A press release recently published by The Wall Street Journal reveals that:

…Parexo Labs leverages Azaya’s twin capabilities in cytotoxic and nanoparticle analysis and liposome manufacturing, including its proprietary analytical methodology to detail release rates and characterization attributes of nanoparticles. Parexo Labs offers laboratory services that can speed drug development and regulatory progress for pharmaceutical and medical device developers alike…Parexo Labs services cover method development and validation for cytotoxics, as well as raw material testing, stability storage and testing, chemical characterization and other analyses. Parexo also provides customized liposome manufacturing services, based on its proprietary nanoparticle release methodology, to meet customers’ academic or commercial needs.

Parexo-Labs-Logo“Azaya Therapeutics has over ten years of experience in the cytotoxic and nanotechnology arenas, which we are now leveraging with the rollout of Parexo Labs,” Azaya’s CEO and President Mike Dwyer explains.”Through Parexo, we can apply these analytical capabilities and development methodologies to organizations in need of them for their own development programs.” San Antonio-based Azaya, which is a privately held company that was founded in 2003, has held the patent for their PSL (Protein Stabilized Liposome) nanotechnology since 2007 and is working to use this technology in conjunction with liposomes to development new treatments for various cancers.

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* Don Wright Interview by Dr. Sanjay Gupta

KOSIK: And every week, Dr. Sanjay Gupta brings us incredible stories of recovery and survival from around the world. In today’s “Human Factor,” our chief medical correspondent reports on a 71-year-old who’s continued his dream of running marathons while fighting a dangerous form of cancer, one where patients are rarely cured.

http://www.cnn.com/video/#/video/health/2013/01/09/human-factor-don-wright.cnn

SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Don Wright’s career spanned engineering, being a company vice president, and the law. At age 62, he discovered a new passion — marathons. Nine year ago, days after running his first 26-mile race, he got some devastating news.

DON WRIGHT, MARATHON RUNNER/CANCER PATIENT: I had gone to the doctor a couple of times for pain in my back. It was multiple myeloma.

GUPTA: This is a cancer of the blood where the white blood cells invade the bone marrow causing pain, usually in the back or the ribs. Patients are rarely cured. But Wright refused to let that slow him down, even qualifying for the Boston marathon.

WRIGHT: We got this devastating diagnosis, and we just — my family and I, we just kept on going. You know, there wasn’t any reason to stop and be sorry, you know. We kept running marathons.

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WRIGHT: It feels wonderful, I’ll tell you. A philosophy of life that I have is live one day at a time and make it a masterpiece, and that was a masterpiece.

GUPTA: Wright wasn’t sure he could fulfill his dream because the median survival for his cancer is just five years. Prognosis does vary depending on age and stage of the disease. He’s had a number of treatments that have failed. But for the last four-and-a-half years, Wright’s taken an experimental drug, one pill at night, that’s worked. It’s kept the cancer at bay.

WRIGHT: It doesn’t cure the cancer, but it keeps it stable so it’s not hurting me. And I can still run. And I can still enjoy life, and I’m riding that for all it’s worth.

GUPTA: His advice to others facing what seemed like insurmountable odds, take charge of your own destiny and never give up hope.

Dr. Sanjay Gupta, CNN, reporting.

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* A Minnesota man who has incurable cancer hits a big milestone

http://www.kvue.com/news/182916671.html

by WCNC

kvue.com

Posted on December 10, 2012 at 8:43 PM
Updated Tuesday, Dec 11 at 7:18 AM

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A Minnesota man who has incurable cancer hits a big milestone.

Seventy-one-year-old Don Wright reached his goal of running marathons in all 50 states. He hit 50 this Sunday in Honolulu.

“My family and I have been running marathons in every state, and that’s been our goal, and we’ve run marathons now in 49 of the 50 states,” Wright said before the race on Sunday, “The diagnosis for my cancer was a three to five-year median survival. It feels like when I’m running along in a marathon, I’m just sticking my finger right in that cancer’s eye.”

Wright has a type of blood cancer.

He says he’s been able to control his battle thanks to a drug that’s being used in clinical trials.

And, he says he’ll keep running as long as he can.

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* Cancer survivor runs his 50th marathon in the 50th state

http://www.hawaiinewsnow.com/story/20292980/cancer-survivor-runs-his-50th-marathon-in-the-50th-state

Cancer survivor runs his 50th marathon in the 50th state

Posted: Dec 07, 2012 10:42 PM EST Updated: Dec 08, 2012 1:43 AM EST

By Teri Okita – bio | email

HONOLULU (HawaiiNewsNow) –

Come Sunday morning, organizers are expecting more than 31,000 runners at the Honolulu marathon. In that crowd, a Minnesota man will, appropriately, be running his 50th marathon in the 50th state.

But Hawaii News Now found out: there’s much more to his story.

Don Wright has had plenty of practice crossing the finish line. This Sunday, he’ll have run a 26.2 mile marathon in every state in the nation.

“That’s pretty. I can’t wait ’til I’m running under that!” says Wright – as he looks at the finish line sign that’s not even hung up yet.

At age 71, not many people can say they’ve finished one marathon – let alone 50. It’s pretty impressive for a guy who just picked up running decade ago.

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Age is the least of his challenges. The St. Paul-area man was diagnosed with multiple myeloma – a blood cancer that affects cells in bone marrow. He was given about five years to live – that was nine years ago.

Running became his path to survival.

“It gives me a chance to make a point that people who have cancer can still have active, vital lives,” he says.

When Wright crosses the finish line on Sunday, he figures he will have logged 12,000, maybe 13,000, miles training and running these marathons.

Do the math. That’s like running from one coast to another – Los Angeles to New York – almost five times! His last marathon was just five weeks ago, and in 2011, he ran more than one marathon a month.

“He’s a runner, not a myeloma victim,” says his wife, 73 year old, Ardis. The Wrights and their daughter often race with together.

He’s stabilized on an investigative cancer drug called pomalidomide and needs no infusions or transplants. “We’re free because all he has is that little pill bottle, and he takes one pill every night and we can go,” says Ardis.

And go they do – successfully on the run from cancer.

Copyright 2012 Hawaii News Now. All rights reserved.

Posted on

* Man with incurable cancer looks to complete quest to run marathons in all 50 states

Man with incurable cancer looks to complete quest to run marathons in all 50 states

Reported by: Olena Heu

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Click here to read the full article and see the video

One of the participants in Sunday’s Honolulu Marathon has overcome many obstacles to get here. The Minnesota resident was diagnosed with an incurable cancer.

Don Wright, 71, says he loves to run.

“I feel like I am floating past the scenery and just gliding along watching it go by,” Wright said.

Nearly 10 years ago, just days after Don’s first marathon, he was diagnosed with myeloma, which is a cancer of the blood.

“The diagnosis for my cancer was a three-to-five year median survival,” Wright said.

Inspired not to let the disease keep him down, the Minnesota resident decided to keep running.

“My family and I have been running marathons in every state. That’s been our goal and now we’ve run marathons in 49 of the 50 states,” Wright said.

When he completes the Honolulu Marathon on Sunday Don will achieve his goal of running 50 marathons in all 50 states…in the 50th state.

“It feels like when I am running along in a marathon like I have just stuck my finger right in that cancer’s eye,” Wright said.

Don runs with the hope of raising funds and awareness for The Tackle Cancer Foundation and has been able to control his battle with cancer thanks to a drug currently being used in clinical trials for his condition.

“That has kept it stable for five years and I actually feel very good,” Wright said.

Will this be his last marathon?

“This will never, no, no I will keep running marathons until I can’t, and that’s hopefully a long way off,” Wright said.

Click HERE to view Wright’s running blog.

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* 50-state marathon runner stops in N.M.

50-state marathon runner stops in N.M.

http://www.koat.com/news/new-mexico/albuquerque/Marathon-Man/-/9153728/17072524/-/4xbrdv/-/index.html

Despite incurable cancer, man runs in dozens of marathons
Published 10:02 AM MDT Oct 21, 2012
ALBUQUERQUE, N.M. –
A Minnesota man diagnosed with an incurable form of cancer is on the run of his life as tries to run 50 marathons in 50 states.

Action 7 News reporter Tanya Mendis spoke with Don Wright on Sunday about his drive to keep running no matter what.

Wright said he was diagnosed with myeloma at 62. Nine years later, the 71-year-old has run marathons in 48 states.

Wright said he hopes to make New Mexico his 49th state.

“When I run, to be honest, I feel like I’m poking that cancer right in the eye,” Wright said.

So far he has run 69 marathons in 48 states.
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“I’d like people to be healthy and think healthy and if I’m an inspiration, that’s all the better,” Wright said.

He said he wouldn’t been able to run more than a few miles, if not for a special trial cancer drug he began four years ago.

“Which for me has turned out to be a miracle drug. It keeps the cancer stable, it doesn’t cure the cancer but it keeps it at a level where the cancer doesn’t hurt me,” Wright said.

He said he might not ever fully escape his cancer but he’s giving it the race of his life.

“The cancer numbers went down to about one-third of what they were to where it’s safe,” Wright said.

Wright did admit that he’s a little old to be running five or six days a week but he doesn’t plan to stop running marathons.

Wright will take part in the Duke City Marathon on Monday.
He said he plans on running his 50th and final state in Hawaii in December.

After that, he might try Canada.